BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA EXCEL 23KHZ TUBING SET

    MDR report key: 6191717 · Received December 20, 2016

    Report

    Report Number
    2648988-2016-00058
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 25, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 02/03/2017. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE REVIEW OF DEVICE HISTORY RECORDS REVIEW OF COMPLAINTS HISTORY RESULTS: ONE (1) UNIT FROM CATALOG C3600, CUSA EXCEL 23 KHZ TUBING SET CORRESPONDING TO FG LOT # 1161324 WAS RECEIVED FOR EVALUATION. THE EVALUATION OF THE COMPLAINT UNIT COULD NOT CONFIRM THE REPORTED CONDITION SINCE IT WAS OBSERVED THAT THE PACKAGE OF THE RETURNED UNIT WAS RECEIVED OPENED. DEVICE HISTORY RECORD (DHR) OF MANUFACTURING LOT 1161324 OF CUSA EXCEL 23 KHZ TUBING SET, WAS REVIEWED. ACCORDING TO THE DHR REVIEW, NO ANOMALIES WERE REPORTED DURING THE PACKAGING PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION. AFTER REVIEWING THE COMPLAINT FROM NOVEMBER 2014 TO NOVEMBER 2016, FIVE (5) COMPLAINTS RELATED TO ¿HAIR FOUND IN STERILE PACKAGING¿ (INCLUDING THE COMPLAINT BEING INVESTIGATED) HAVE BEEN REPORTED IN THE CUSA MANIFOLD TUBING FAMILY AT INTEGRA LIFESCIENCES (B)(4) FACILITY. APPROXIMATELY (B)(4) UNITS OF CUSA MANIFOLD TUBING FAMILY PRODUCTS HAVE BEEN SHIPPED FOR SALES PURPOSES FROM NOVEMBER 2014 TO NOVEMBER 2016, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). CONCLUSION: BASED ON THE DESCRIPTION OF THE REPORTED EVENT AND THE PRODUCT FAILURE ANALYSIS, THE REPORTED CONDITION ¿HAIR FOUND IN STERILE PACKAGING¿ COULD NOT BE CONFIRMED SINCE THE ORIGINAL PACKAGE WAS OPENED. EVEN SO, THE IMPLEMENTATION OF AN OPEN FACE HOOD AS PART OF CAPA WAS IMPLEMENTED ON 09/15/16 AND THE FG LOT 1161324 WAS MANUFACTURED ON 04/19/16. THEREFORE, THE FG LOT 1161324 WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF CAPA. RISK CONTROL PROCEDURES AND SOPS ARE IN PLACED TO REDUCE THE PROBABILITY OF OCCURRENCE OF THIS EVENT. TWO CLEANING TECHNIQUES¿ALCOHOL WIPES AND AIR BLOW-OFFS ARE USED IN OUR MANUFACTURING OPERATIONS, BOTH OF WHICH SEEK TO ELIMINATE UNWANTED PARTICLES ON DEVICE SURFACES. DURING THE MANUFACTURING PROCESS, THE MANIFOLD TUBING IS CLEANED WITH ALCOHOL WIPES. THIS METHOD REMOVES THE STATIC CHARGE ON THE SURFACE TEMPORARILY. ONCE THE ALCOHOL WIPE-DOWN HAS BEEN PERFORMED, AIR BLOW-OFFS IS FOLLOWED. TO ELIMINATE ALL PARTICLES, THE MANIFOLD TUBING ASSEMBLY IS SPRAYED WITH IONIZING AIR. IONIZED AIR BLOW-OFFS ARE EFFECTIVE AT REMOVING PARTICLES FROM THE DEVICE SURFACE, PREVENTING RECHARGING AND SUBSEQUENT PARTICLE ATTRACTION. THE COMPLETION OF THESE STEPS WAS REVISED DURING THE DHR REVIEW. FOR THIS PARTICULAR LOT, NO ANOMALIES WERE FOUND. UNITS ARE 100% INSPECTED FOR CONTAMINATION AND FOREIGN MATERIAL ON THE DEVICE. NO ANOMALIES RELATED TO THE REPORTED CONDITION WERE OBSERVED DURING THE MANUFACTURING PROCESS OF THE LOT 1161324 ACCORDING TO THE DHR REVIEW. SINCE THE COMPLAINT UNIT WAS RECEIVED OPENED, AND THERE WERE NO ANOMALIES FOUND IN THE MANUFACTURING PROCESS, THE POTENTIAL ROOT CAUSE MAY BE RELATED THAT A HAIR FELL INTO THE OPENED PACKAGING IN THE FIELD.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT WAS PREPPED FOR SURGERY WHEN THE C3600 CUSA EXCEL 23KHZ TUBING SET WAS FOUND TO HAVE A HAIR IN THE STERILE PACKAGING. THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY DUE TO THE INCIDENT. ANOTHER TUBING SET WAS OBTAINED AND THE PROCEDURE PROCEEDED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840219 CUSA EXCEL 23KHZ TUBING SET ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 0000001161324

    Patients

    Seq Age Sex Outcome Treatment
    1